ST LOUIS (MD Consult) - Nature & Health Co, located in Brea, Calif., has announced a voluntary nationwide recall of the company's libido supplement product Libimax.
The company has been informed by representatives of the US Food and Drug Administration (FDA) that lab analysis by the FDA of Libimax samples found the product contains tadalafil, an active ingredient of an FDA-approved drug for erectile dysfunction (ED), making Libimax an unapproved drug. The FDA said this poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels.
People with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. Erectile dysfunction is a common problem in men with these conditions, the FDA said, and they may seek products to enhance sexual performance. Tadalafil may cause adverse effects such as headaches and flushing.
The recalled Libimax is sold as a 1-capsule individual pack or as 10-capsule and 20-capsule plastic bottles in retail stores in California, Georgia, Illinois, Texas, and Ohio. The product label neither states it contains tadalafil nor warns consumers with high blood pressure not to ingest the product.
Consumers who have Libimax should stop using it immediately and contact their physician if they experienced any problem that may be related to taking this product. The public is encouraged to submit a report of any serious adverse events that occur with the use of Libimax to the FDA's MedWatch Adverse Event Reporting program.
- Online: Go to www.fda.gov/MedWatch/report.htm;
- Phone: Call 1-800-FDA-1088;
- Mail: Send the postage-paid FDA form 3500, which may be downloaded from www.fda.gov/MedWatch/getforms.htm, to MedWatch, 5600 Fishers Lane, Rockville, MD 20852-9787;
- Fax: Send to 1-800-FDA-0178.
Nature & Health Co is committed to providing accurate information about its products and is working with the FDA in the recall process. To date, no illnesses have been reported to the company in connection with this product.
Consumers should return any unused Libimax for a refund of the full purchase price or price for the unused portion to the retail location where it was purchased. They can also contact Nature & Health directly at (714) 257-1800 Monday through Friday, 8 AM to 5 PM, or by email at sales@naturenhealth.com with any questions or to receive further instructions for returning the product.
圣路易斯(MD Consult)——位于加利福尼亚州布瑞亚的Nature & Health公司宣布在全国范围内自愿召回性欲膳食补充剂产品Libimax。
美国食品和药物管理局(FDA)已向该公司发出一份通报，称 FDA实验室分析发现该公司的Libimax含有未经申报的治疗勃起功能障碍(ED)的他达拉非。美国FDA指出这对消费者构成了威胁，因为他达拉非可能会与一些处方药(如硝酸甘油)的硝酸盐发生作用，引起血压下降至危险水平。
糖尿病、高血压、高胆固醇或心脏病患者往往会服用硝酸盐类药物。勃起功能障碍是男性常见的问题，他们可能服用性保健品，以提高性功能。他达拉非可能会导致诸如头痛和面红等副作用。
被召回Libimax的规格有1粒单独装或每10 粒和20粒塑料瓶装，在加利福尼亚、佐治亚、伊利诺伊、得克萨斯和俄亥俄州的零售商店均有销售。该产品说明书没有说明含有他达拉非，也没有提醒患有高血压的消费者不得使用本品的警告。
消费者应立即停止使用Libimax，如果遇到可能涉及到该产品的任何问题应联系本人的医生。鼓励公众对使用Libimax出现的任何严重不良事件向FDA的MedWatch不良事件报告项目组报告。
•网络：请登录MedWatch网站www.fda.gov/medwatch
•电话：请拨打1-800-FDA-1088；
•邮件：请从www.fda.gov/MedWatch/getforms.htm下载已付邮资的FDA3500表格，并寄至MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787；
•传真：请发至1-800-FDA-0178；
Nature & Health公司保证其提供的产品信息的准确性，目前正在与FDA一道进行产品的召回。迄今为止，该公司此类产品消费者未报告发生任何身体不适。
消费者应在购买处退还未使用的Libimax问题产品，可获得全额退款，使用过的产品则可获得部分退款。消费者如有疑问或需接受进一步的退货指导，请在每周一至周五上午8点到下午5点致电714-257-1800或通过电子邮件sales@naturenhealth.com直接联系Nature & Health公司。
